Pharmaceutical product for injection

Abstract

The claimed subject matter is related to a pharmaceutical product for injection comprising a container including a closure suitable for preparations for injection, the container containing an acid labile proton pump inhibitor, a salt thereof, a solvate of the acid labile proton pump inhibitor or a salt thereof, wherein the container and closure are made of material which essentially does not release zinc ions.

1 - 20 . (canceled) 
     
     
         21 . A pharmaceutical product for injection comprising a container including a closure suitable for preparations for injection, the container containing a compound selected from the group of 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole (pantoprazole), a salt thereof, a solvate of pantoprazole and a salt thereof, wherein the container and closure are made of material which essentially does not release zinc ions, whereby the closure is a rubber stopper of type 1 according to European Pharmacopoeia 2002, wherein the amount of extractable zinc from the closure is 0 ppm (i.e. not detectable), when determined according to European Pharmacopeia 2002, and wherein the product comprises a clear glass vial fitted with said rubber stopper and a crimp seal. 
     
     
         22 . The pharmaceutical product according to  claim 21 , wherein pantoprazole is pantoprazole sodium sesquihydrate. 
     
     
         23 . The pharmaceutical product according to  22 , wherein the closure is a freeze-drying closure. 
     
     
         24 . The pharmaceutical product according to  claim 21 , wherein the closure is a butyl rubber stopper of type 1 according to European Pharmacopeia 2002, which is partially fluoro-polymer laminated. 
     
     
         25 . The pharmaceutical product according to  claim 21 , wherein the glass vial comprises a blow back inside the flange, and the closure is a butyl rubber stopper of type 1 according to European Pharmacopoeia 2002 having 0 ppm of extractable zinc, which stopper is partially fluoro-polymer laminated. 
     
     
         26 . The pharmaceutical product according to  claim 25 , wherein the fluoro-polymer lamination extends from the area of the stopper surface following the area of the stopper which is contacting the blow back inside the flange of the vial downwards and covers those parts of the stopper which extend inside the vial. 
     
     
         27 . The pharmaceutical product according to  claim 21 , having reduced pressure inside the container. 
     
     
         28 . The pharmaceutical product according to  claim 27 , wherein the reduced pressure is 800 mbar or below, 600 mbar or below or 500 mbar or below. 
     
     
         29 . The pharmaceutical product according to  28 , having a volume of 20 ml or less. 
     
     
         30 . The pharmaceutical product according  21 , additionally containing one or more suitable excipients. 
     
     
         31 . The pharmaceutical product according to  claim 30 , wherein the excipients are selected from the group of complexing agents, stabilizers, suitable bases, carriers and mixtures thereof. 
     
     
         32 . The pharmaceutical product according to  claim 31 , comprising ethylendiamine tetraacetic acid and/or a suitable salt thereof and sodium hydroxide. 
     
     
         33 . A process for manufacturing a pharmaceutical product for injection according to  claim 21  comprising the steps of (a) providing a mixture of a compound selected from the group of 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole (pantoprazole), a salt thereof, a solvate of pantoprazole and a salt thereof, with a solvent and optionally further excipients in the container (b) subjecting the container comprising the above mixture to freeze drying and (c) closing the container with the closure. 
     
     
         34 . The process according to  claim 33 , wherein step (c) is affected under reduced pressure. 
     
     
         35 . A pharmaceutical product for injection comprising a container including a closure suitable for preparations for injection, the container containing a compound selected from the group of 5-difluoromethoxy-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole (pantoprazole), a salt thereof, a solvate of pantoprazole and a salt thereof, wherein the container and closure are made of material which essentially does not release zinc ions, whereby the closure is a rubber stopper of type 1 according to European Pharmacopoeia 2002, wherein the amount of extractable zinc from the closure is 0 ppm (i.e. not detectable), when determined according to European Pharmacopeia 2002, and which was manufactured without the use of zinc-containing components, and wherein the product comprises a clear glass vial fitted with said rubber stopper and a crimp seal. 
     
     
         36 . The pharmaceutical product according to  claim 35 , having reduced pressure inside the container. 
     
     
         37 . The pharmaceutical product according to  claim 36 , wherein the reduced pressure is 800 mbar or below, 600 mbar or below or 500 mbar or below. 
     
     
         38 . The pharmaceutical product according to  claim 35 , additionally containing one or more suitable excipients. 
     
     
         39 . The pharmaceutical product according to  claim 37 , wherein the reduced pressure is 800 mbar or below, 600 mbar or below or 500 mbar or below. 
     
     
         40 . The pharmaceutical product according to  claim 38 , wherein the excipients are selected from the group of complexing agents, stabilizers, suitable bases, carriers and mixtures thereof.